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A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

Primary Purpose

Growth Hormone Deficiency

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PHA-794428
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1.Male and female children with a minimum age of 6 years 2. Prepubertal as defined by Tanner staging 3. Growth hormone deficiency Exclusion Criteria: 1. PGHD patients with uncontrolled pituitary tumor growth 2. Tumors within 3 mm of the optic chiasm 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

PK, IGF-1 and safety measurements up to 2 weeks after dosing

Secondary Outcome Measures

Antibody and IGFBP-3 measurements

Full Information

First Posted
April 13, 2006
Last Updated
May 12, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00314938
Brief Title
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
Official Title
A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling
Detailed Description
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PHA-794428
Primary Outcome Measure Information:
Title
PK, IGF-1 and safety measurements up to 2 weeks after dosing
Secondary Outcome Measure Information:
Title
Antibody and IGFBP-3 measurements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Male and female children with a minimum age of 6 years 2. Prepubertal as defined by Tanner staging 3. Growth hormone deficiency Exclusion Criteria: 1. PGHD patients with uncontrolled pituitary tumor growth 2. Tumors within 3 mm of the optic chiasm 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1050
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Pfizer Investigational Site
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Pfizer Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6391004&StudyName=A%20single%20dose%20study%20to%20evaluate%20the%20PK-PD%20response%20and%20safety%20of%20PHA-794428%20in%20children%20with%20growth%20hormone%20deficiency
Description
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Learn more about this trial

A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

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